Patent SG-11201407679P-A (SG)
Title: Manufacture of degarelix
Inventor: SCHWACH GRÉGOIRE
IPC: A61K38/09
Filed: 2013-05-31
Abstract: (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 5 December 2013 (05.12.2013) WIPOIPCT (10) International Publication Number WO 2013/178788 A3 (51) International Patent Classification: A61K38/09 (2006.01) A61K 9/00 (2006.01) A61K 47/12 (2006.01) (21) International Application Number: (22) International Filing Date: (25) Filing Language: (26) Publication Language: PCT/EP2013/061264 31 May 2013 (31.05.2013) English English (30) Priority Data: 12170454.8 1 June 2012 (01.06.2012) EP (71) Applicant: FERRING B.V. [NL/NL]; Polaris Avenue 144, NL-2132 JX Hoofddorp (NL). (72) Inventors: SCHWACH, Gregoire; Gammel Kongevej 25, 2tv, DK-1610 Copenhagen (DK). NILSSON, Anders; Korsakersvagen 37, S-226 50 Lund (SE). GOTT- SCHALK BOEVING, Tine Elisabeth; Boveskowej 4, DK-2800 Kgs. Lyngby (DK). RASMUSSEN, Jon Hol- bech; Solvaenget 20, DK-2800 Lyngby (DK). MORN- STAM, Birgitta; Vastra Kalkbrottsgrand 43, S-216 11 Limhamn (SE). TSIRK, Anders; Henrik Smithsgatan 3, S- 211 56 Malmo (SE). ANNBY, Ulf; Norrangavagen 2A, S- 22 477 Lund (SE). FOMSGAARD, Jens; Vinkelvej 27, DK-3520 Farum (DK). (74) Agents: RENKEN, Joachim / HOFFMANN EITLE • et al.; Arabellastrasse 4, 81925 Munich (DE). (81) Designated States (unless otherwise indicated, for every kind of national protection available)'. AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available)'. ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Published: — with international search report (Art. 21(3)) — before the expiration of the time limit for amending the claims and to be republished in the event of receipt of amendments (Rule 48.2(h)) (88) Date of publication of the international search report: 27 February 2014 00 00 l> 00 l> i-H o CJ (54) Title: MANUFACTURE OF DEGARELIX (57) Abstract: The present invention provides methods for producing lyophilized degarelix a product which, upon reconstitution with water for injection in an amount of 20 mg/ml, shows a viscosity of up to 15 mPas. The present invention also provides lyo a - philized degarelix drug substance which shows, upon dissolution in water in an amount of 20 mg/ml, viscosity of a up to 3.2 mPas, and processes for providing this lyophilized degarelix drug substance.